BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEGA INNOVATIONS, INC.

    MDR report key: 16582517 · Received March 21, 2023

    Report

    Report Number
    16582517
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 6, 2023
    Manufacturer
    CEGA INNOVATIONS, INC.
    Product Code
    FMR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AFTER INFLATION OF THE REMUV SINGLE PATIENT USE (SPU) AIR TRANSFER MATTRESS, AN AIR BAFFLE POPPED AND PATIENT TILTED SIDEWAYS, HAD TO DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17242 CEGA INNOVATIONS, INC. DEVICE, TRANSFER, PATIENT, MANUAL FMR CEGA INNOVATIONS, INC. MV800 CEGA2021004

    Patients

    Seq Age Sex Outcome Treatment
    1 31755 DA Unknown